Quality Assurance jobs in Canada
Boston Scientific Senior Quality Design Assurance Engineer / Canada, Quebec, Montreal
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Additional Location(s): Canada-QC-Montreal
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role
The ideal Senior Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative cardiovascular products. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
Your responsibilities will include:
- Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
- Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
- Provide quality and compliance input for post market product sustaining activities, such as design changes, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
- Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
- Builds quality into all aspects of work by maintaining compliance to all quality requirements.
- Support internal and external regulatory audits as required.
- Other duties as necessary or required by the organization.
Required qualifications:
- Bachelor’s degree in mechanical, electrical, or biomedical engineering, or equivalent.
- 7+ years of work experience relating to quality assurance in a highly regulated industry.
- Medical device experience
- Competent with use of Microsoft Office Suite
Preferred Qualifications
- Focus on detailed work with emphasis on accuracy and completeness
- Excellent organizational and planning skills; drives for results
- Strong communication (oral and written) and presentation skills
- High energy problem solver capable of driving items to closure
- Ability to collaborate and work on a global team
À propos du poste
L’ingénieur principal en assurance de la qualité de la conception idéal exerce son leadership dans le cadre de projets de développement de nouveaux produits et de projets de soutien pour nos produits cardiovasculaires novateurs. En outre, il développe, établit et assure la mise en œuvre de méthodologies, de systèmes et de pratiques d’ingénierie appliqués à l’assurance de la qualité qui répondent aux exigences de BSC, des clients et des autorités de réglementation.
Responsabilités
- Comprendre les contrôles de conception, la gestion des risques et la facilité d’utilisation des dispositifs médicaux.
- Fournir des informations sur la qualité et la conformité aux équipes responsables des projets en ce qui concerne les décisions à prendre et les produits livrables (c’est-à-dire l’analyse des changements relatifs à la conception, les données d’entrée de la conception, les données de sortie de la conception, les méthodes d’essai, les revues de la conception, la vérification et la validation de la conception, les essais de facilité d’utilisation, la validation des logiciels, la validation des processus et l’étiquetage).
- Fournir des informations sur la qualité et la conformité pour les activités de soutien des produits après leur mise sur le marché, telles que les modifications de la conception, les événements de non-conformité, les besoins d’information prioritaires concernant les actions correctives et préventives, les évaluations des signaux sur le terrain et les actions sur le terrain.
- Appliquer des compétences techniques, y compris des méthodologies éprouvées et systématiques de résolution des problèmes pour identifier, hiérarchiser, communiquer et résoudre les problèmes de qualité.
- Collaborer au sein d’une équipe afin d’identifier et de mettre en œuvre des contrôles efficaces pour soutenir le développement ou la maintenance des produits afin de répondre aux exigences internes et externes.
- Intégrer la qualité dans tous les aspects du travail en maintenant la conformité à toutes les exigences de qualité.
- Soutenir les audits réglementaires internes et externes, le cas échéant.
- Exécuter d’autres tâches requises ou exigées par la société.
Compétences requises
- Baccalauréat en génie mécanique, électrique ou biomédical dans un domaine ou équivalent
- Plus de 7 ans d’expérience professionnelle en matière d’assurance de la qualité dans un secteur hautement réglementé
- Expérience dans le domaine des dispositifs médicaux
- Maîtrise de la suite d’applications Microsoft Office
Compétences souhaitées
- Capacité à se concentrer pour effectuer un travail minutieux en mettant l’accent sur l’exactitude et l’exhaustivité
- Excellentes capacités en matière d’organisation et de planification; volonté d’obtenir des résultats
- Solides compétences en matière de communications (orales et écrites) et de présentation
- Excellente capacité à résoudre les problèmes et à mener les dossiers à terme
- Capacité à collaborer et à travailler au sein d’une équipe internationale
Requisition ID: 617682
Minimum Salary: $79700
Maximum Salary: $158200
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for hourly, non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).
Our organization is across Canada and has commercial representation in 140 countries.
This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.
As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualité position require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualité position.
However, in Québec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee’s duties.
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EY Senior Consultant - Financial Transaction Reporting Assuranc... Canada, Quebec, Montreal
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You will be called upon to leverage your skills, professional experience, and interpersonal abilities to support clients through their transactions, while collaborating with other EY departments (primarily valuation and taxation).
Your key responsibilities
- Develop and maintain productive relationships with client management throughout the year.
- Establish expectations of value to be delivered.
- Participate in transaction execution, focusing mainly on complex or specialized issues (IFRS, ASPE, U.S. GAAP).
- Create reports and other deliverables.
- Understand the client's industry and recognize key performance drivers, business trends, and emerging technical and industry developments.
- Stay informed of general business/economic developments and their impact to the client.
- Develop people by encouraging individuals to think for themselves and take responsibility for their contributions to the team.
- Use technology to continually learn, share knowledge with team members, and enhance service delivery.
- Demonstrate detailed understanding of key concepts and principles related to application of complex accounting standards, finance process improvements, project management and change management; show an ability to apply these consistently in engagement settings
- Monitor the engagement team's progress against the plan and alter it when needed.
- Develop long-term relationships and networks both internally and externally.
Skills and attributes for success
- Accounting expertise in IFRS, US GAAP and ASPE
- Ability to research accounting topics using a variety of sources and apply to transactions or contracts to develop accounting policy examples or recommendations. Experience preparing technical accounting memos or papers to define a transaction and provide application to accounting guidance for clients and EY executives
- Plan, manage and participate in various engagements (researching application of accounting standards to various transactions, assessing financial and governance processes, assisting with accounting framework transitions, comparisons of different company practices, developing and providing tailored training, etc.)
- Advanced written and verbal communication skills
- Proven ability to lead a team and develop business opportunities
- Knowledge of business trends, emerging technical and industry developments
- Excellent leadership and project management skills
- Able to manage multiple engagements and deadline-driven
Ideally, you'll also:
- A degree in accounting and/or other appropriate academic major and a minimum of 3-5 years’ relevant experience along with CPA, CA designation or equivalency
- Audit or business experience in financial statement close or the application of accounting standards
- Demonstrate mastery of key concepts and principles related to process improvements, project management and change management; show an ability to apply these consistently in engagement settings
- Impeccable client relationship skills
- A dedication to teamwork and leadership
- Commitment to delivering high-quality work.
- This role involves interaction with clients operating nationally and globally where fluency in French and English is required. Bilingualism in both French and English is therefore a requirement of this role.
What we offer
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our Total Rewards package allows you decide which benefits are right for you and which ones help you create a solid foundation for your future. Our Total Rewards package includes a comprehensive medical, prescription drug and dental coverage, a defined contribution pension plan, a great vacation policy plus firm paid days that allow you to enjoy longer long weekends throughout the year, statutory holidays and paid personal days (based on province of residence), and a range of exciting programs and benefits designed to support your physical, financial and social well-being. Plus, we offer:
- Support and coaching from some of the most engaging colleagues in the industry
- Learning opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
These jobs might be a good fit
EY Senior Manager- Technology Risk - Assurance Canada, Alberta, Calgary
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Your key responsibilities
The candidate will be required to participate in both internal and external audit services. This includes, but not limited to:
Business development:
- Identify and pursue new business opportunities within the technology risk domain.
- Develop and execute strategies to expand the client base, increase market share & achieve revenue targets
- Collaborate with other EY service lines to cross-sell and deliver integrated solutions to clients.
- Contribute to the development and execution of the go-to-market strategy for the Technology Risk group.
- Stay abreast of industry trends, emerging risks, and regulatory changes to inform service offerings and market positioning.
- Represent EY at industry events, conferences, and forums to enhance the firm's visibility and reputation and play a pivotal role in augmenting EY’s footprint in the market.
- Build a robust pipeline of prospective clients & enhance relationships with current and potential clients.
- Work with teams and personal networks to generate new business opportunities.
- Participate in high visibility industry initiatives/forums to enhance EY’s brand value and showcase EY’s service and product capabilities.
- Lead business development initiatives including service offering development and roll-out, proposal development, responding to RFP’s, presentations, and negotiations with potential clients and contribute to the development of engagement plans and proposals for client needs.
- Work in collaboration with your local market leader in growing the Technology Risk services market shares and enhancing our presence in key sectors and accounts.
- Build strong internal relationships within our national and global Technology Risk practice and across EY’s service lines including Advisory, Tax and Transactions.
Client Management:
- Develop and maintain strong relationships with key clients, understanding their business needs and providing tailored risk management solutions.
- Act as the primary point of contact for clients, ensuring high levels of client satisfaction and addressing any issues or concerns promptly.
- Lead client engagements, including planning, execution, and delivery of technology risk services.
Leadership and Team Development:
- Lead and provide relevant support to the teams of managers, senior consultants and consultants, including delivering formal IT Audit related trainings.
- Provide leadership and guidance to project teams, fostering a collaborative culture of high-performance, excellence and continuous improvement.
- Lead and support partners in practice management aspects.
Execution and Delivery Excellence:
- External audits: Oversee engagements to test and opine on efficacy of IT general controls (ITGCs) and IT application controls (ITACs) to support financial statement audits / integrated audits (Internal Controls for Financial Reporting).
- Internal audits/SOX compliance testing: Assist clients in designing and implementing ITGCs and ITACs to support SOX compliance. Oversee testing of ITGCs and ITACs to confirm efficacy of controls.
- Service organization reporting – Focus on the issuance of third-party reports in the form of 3416 reports, SOC 1, SOC 2 reports, etc.
- Provide high quality professional day-to-day management of internal/external audit engagements/projects.
- Lead and support on-site coordination for audit clients including planning, briefing team on the client's IT environment and industry IT trends, communicating with the clients and completing audit engagements
- Prepares IT external audit reports on the adequacy and effectiveness of control structure, along with practical recommendations to improve the effectiveness, efficiency of a control or process.
- Able to discuss and resolve audit issues and recommendations with client management.
- Demonstrate a thorough understanding of complex information systems and apply it to client situations
- Ensure compliance with regulatory requirements and industry best practices & EY's methodologies, policies, and quality standards.
Skills and attributes for success
- Extensive experience in technology risk management, with a focus on business development and market development with a proven track record of successfully developing and executing business development strategies
- Strong understanding of technology risk, cybersecurity, and regulatory requirements
- Strong project management, analytical, interpersonal and communication skills and a strong desire to work in a team environment
- Demonstrated integrity, values, principles, and work ethic
- Strong experience interacting with clients at all levels including Leadership and Partners: Strong written, communication, and presentation skills
To qualify for the role you must have
- Minimum 8+ years of experience in IT external and/or internal audit;
- Bachelor’s Degree (or higher) in Business Administration, Commerce, Computer Science, Management Information Systems, or other relevant program required.
- Must possess relevant audit and/or accounting designation(s) (e.g. CISA, CPA, CIA, etc.) is required
Ideally, you’ll also have
- Demonstrated knowledge of COBIT, ITIL, or other IT frameworks and service organization reporting standards would be an asset
- Demonstrated knowledge of specific platforms such as SAP, Oracle, Windows, etc. would be an asset
- Hands on experience with project management or IT operations based in large enterprise resource planning systems such as Oracle Financials, SAP, etc. or information security would be an a
What we look for
We’re interested in highly motivated talented individuals with a strong willingness to think outside of the box. You can expect plenty of autonomy in this role, so you’ll need the motivation to take initiative and seek out opportunities to improve our current relationships and expand our business in the evolving market. If you’re serious about consulting and ready to take on some of our clients’ most complex issues, this role is for you.
What we offer
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our Total Rewards package allows you decide which benefits are right for you and which ones help you create a solid foundation for your future. Our Total Rewards package includes a comprehensive medical, prescription drug and dental coverage, a defined contribution pension plan, a great vacation policy plus firm paid days that allow you to enjoy longer long weekends throughout the year, statutory holidays and paid personal days (based on province of residence), and a range of exciting programs and benefits designed to support your physical, financial and social well-being. Plus, we offer:
- Support and coaching from some of the most engaging colleagues in the industry
- Learning opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
These jobs might be a good fit
EY Senior Staff Accountant- Audit- Assurance Canada, Quebec, Quebec
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As an Assurance Senior staff accountant, you will be a professional member of our Audit practice. Together with our substantial investments in technology, knowledge, and learning resources for our audit professionals, you will be part of the team that delivers quality assurance services to our clients and their stakeholders.
Your key responsibilities
As an Assurance Senior staff accountant, you will deliver quality assurance services to our clients and their stakeholders.
Skills and attributes for success
- Develop and maintain productive working relationships with client personnel and assess clients' satisfaction.
- Proactively maintain contact with the client throughout the year.
- Direct fieldwork daily, inform supervisors of the engagement status, and manage staff performance.
- Adapt the audit approach to the changing client environment.
- Demonstrate a thorough understanding of complex accounting and auditing concepts and apply them to client situations.
- Develop people through effectively delegating tasks and providing guidance to staff. Provide performance feedback and training, and conduct performance reviews.
- Foster an efficient, innovative, and team-oriented work environment. Contribute ideas/opinions to the audit teams and listen/respond to other team members' views.
- Use technology to continually learn, share knowledge with team members, and enhance service delivery.
- Maintain an educational program to continually develop skills. Develop an understanding of EY's service lines and actively seek/encourage team members to contribute ideas and identify opportunities to apply the firm's services.
- While proficiency in a language other than French is not a requirement for this role, some English communications with stakeholders outside of Quebec may be required from time to time.
To qualify for the role you must have:
- An undergraduate or graduate degree in accounting, and/or an undergraduate or graduate degree
- Successfully passed the Canadian CFE and / or possess a Canadian CA designation, or possess a reciprocal CA designation recognized with the CICA
- A minimum of 2-3 years of experience working as an auditor for a public accounting firm, or particular business/industry experience to meet special needs
- Excellent project management skills, advanced written and verbal communication skills
- A dedication to teamwork and leadership
- Integrity within a professional environment
- This role involves interaction with clients operating nationally and globally. Bilingualism in both French and English is therefore a requirement of this role.
Ideally, you’ll also have
- The ability to work independently in a fast-paced, dynamic team-oriented environment
What we offer
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our Total Rewards package allows you decide which benefits are right for you and which ones help you create a solid foundation for your future. Our Total Rewards package includes a comprehensive medical, prescription drug and dental coverage, a defined contribution pension plan, a great vacation policy plus firm paid days that allow you to enjoy longer long weekends throughout the year, statutory holidays and paid personal days (based on province of residence), and a range of exciting programs and benefits designed to support your physical, financial and social well-being. Plus, we offer:
- Support and coaching from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.
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EY Manager- Financial Transaction reporting- Assurance Canada, Ontario, Toronto
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Your key responsibilities
As a Manager, you will help finance leaders address the challenges and ongoing changes facing their business and manage the resulting repercussions on the accounting and finance function. You will partner with them to achieve their potential in acquisitions, divestitures, IPOs, GAAP conversions, restructuring or accounting standards policy implementation and convergence. In addition, you will create innovative commercial insights for clients, and drive improvements in business processes.
Skills and attributes for success
- Plan, manage and participate in various engagements (researching application of accounting standards to various transactions, assessing financial and governance processes, assisting with accounting framework conversions, comparisons of different company practices, developing and providing tailored training, etc.).
- Prepare deliverables tailored to client needs.
- Supervise engagement teams including delegation and review of work performed.
- Conduct timely performance reviews and provide performance feedback and coaching. Lead by example.
- Establish and maintain relationships with client management.
- Understand the client’s industry and recognize key performance drivers, business trends, and new technical and industry developments.
- Stay informed of changing market conditions and new regulatory developments and their impacts on clients.
- Develop people by encouraging individuals to think for themselves and take responsibility for their contributions to the team, focusing on diversity and inclusiveness.
- Use technology to continually learn, share knowledge with team members, and enhance service delivery.
- Attend training programs to continually develop skills.
- Maintain cooperative relationships and foster mutual support with other EY service line teams.
- Prepare proposals and realize business development plans through a strong professional network.
Ideally, you’ll also have
- A minimum of 5 years’ relevant experience
- accounting designation is a must (e.g. CPA, CA)
- Audit or business experience in the application of accounting standards, including International Financial Reporting Standards (IFRS)
- Impeccable client relationship skills
- A dedication to teamwork and leadership
- The ability to work independently in a fast-paced, dynamic team-oriented environment
- Due to the nature of the role having interactions with National & Global clients, bilingualism in French and English is required for this position
- Experience working with United States Generally Accepted Accounting Principles (US GAAP) and / or Accounting Standards for Private Enterprises (ASPE) is beneficial
- Audit or business experience in financial statement close and the application of Internal Controls over Financial Reporting, with a preference for experience with SOX 404 or National Instrument 52-109 compliance
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EY Manager- Transaction Financial Reporting - Assurance Canada, Quebec, Montreal
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You will be called upon to utilize your skills, professional experience, and interpersonal abilities to support clients throughout their transactions, while working collaboratively with other EY departments (primarily valuation and tax).
As a Manager, you will be a professional member of our Advisory Services, Financial Accounting (SCCF) team. In Canada, our specialized SCCF team consists of financial information and advisory accounting professionals located across five offices. We possess technical accounting expertise in IFRS as well as Canadian and US GAAP, hands-on experience with financial reporting processes, and in-depth regulatory knowledge.
Your key responsibilities
As a Manager, you will help finance leaders address ongoing challenges and changes facing their businesses and manage the resulting impacts on their Accounting and Finance functions. You will work in partnership with them to help realize their potential—particularly in acquisition, divestment, restructuring/optimization projects, or implementation and convergence of accounting standards. Additionally, you will provide innovative business advice and guide improvements to business processes.
Skills and attributes for success
- Plan, manage and participate in various engagements (researching application of accounting standards to various transactions, assessing financial and governance processes, assisting with accounting framework conversions, comparisons of different company practices, developing and providing tailored training, etc.)
- Prepare deliverables tailored to client needs.
- Supervise engagement teams including delegation and review of work performed.
- Conduct timely performance reviews and provide performance feedback and coaching. Lead by example.
- Establish and maintain productive relationships with client leadership and other multidisciplinary teams involved in transaction engagements (M&A, due diligence, valuation, restructuring, tax, etc.).
- Understand the client’s industry and recognize key performance drivers, business trends, and new technical and industry developments.
- Stay informed of changing market conditions and new regulatory developments and their impacts on clients.
- Develop people by encouraging individuals to think for themselves and take responsibility for their contributions to the team, focusing on diversity and inclusiveness.
- Use technology to continually learn, share knowledge with team members, and enhance service delivery.
- Prepare proposals and realize business development plans through a strong professional network.
Ideally, you'll also have:
- A minimum of 5 years’ relevant experience
- Audit or business experience in the application of accounting standards, including International Financial Reporting Standards (IFRS)
- Impeccable client relationship skills
- A dedication to teamwork and leadership
- A commitment to deliverablequality
- The ability to work independently in a fast-paced, dynamic team-oriented environment
- This role involves interaction with clients operating nationally and globally where fluency in French and English is required. Bilingualism in both French and English is therefore a requirement of this role.
What we offer
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our Total Rewards package allows you decide which benefits are right for you and which ones help you create a solid foundation for your future. Our Total Rewards package includes a comprehensive medical, prescription drug and dental coverage, a defined contribution pension plan, a great vacation policy plus firm paid days that allow you to enjoy longer long weekends throughout the year, statutory holidays and paid personal days (based on province of residence), and a range of exciting programs and benefits designed to support your physical, financial and social well-being. Plus, we offer:
- Support and coaching from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
These jobs might be a good fit
EY Legal Translator-Revisor - Translation Services Assurance Canada, Quebec, Montreal
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Main tasks will include:
- Translating and revising tax and legal documents, from English to French
- Managing several assignments at the same time and setting priorities
- Doing terminology research
- Sharing knowledge and expertise with colleagues
- Receiving internal translation requests and communicating with clients in the absence of the manager
- Assigning work to team members in the absence of the manager
Skills and attributes for success:
- Experience in translating contracts, bankruptcy documents, management informationcirculars, annual information forms, offering memoranda and other securities-relateddocuments
- Familiarity with relevant documentary and terminology research, particularly in laws and regulations and as well as on legal information websites and in specialized dictionaries.
- Be able to occasionally work under pressure, within a dynamic team of versatile
To qualify for the role you must have:
- Hold a university degree in Translation at the undergraduate or graduate level
- Have a background in law and/or supervised experience in legal translation
- Have at least 10 years of experience in translation and revision in a structured andsupervised professional environment
- Be able to occasionally work under close time constraints, with a dedicated team of flexible and versatile professionals
- This role involves interaction with clients operating nationally and globally. Bilingualismin both French and English is therefore a requirement of this role
Ideally, you:
- Are a member of OTTIAQ (other professional orders, such as Barreau or CPA, will be taken into consideration)
- Have the ability to work independently in a fast-paced, dynamic team-oriented environment
What we offer:
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business. In addition, our Total Rewards package allows you decide which benefits are right for you and which ones help you create a solid foundation for your future. Our Total Rewards package includes a comprehensive medical, prescription drug and dental coverage, a defined contribution pension plan, a great vacation policy plus firm paid days that allow you to enjoy longer long weekends throughout the year, statutory holidays and paid personal days (based on province of residence), and a range of exciting programs and benefits designed to support your physical, financial and social well-being. Plus, we offer:
- Support and coaching from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.
These jobs might be a good fit
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Additional Location(s): Canada-QC-Montreal
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role
The ideal Senior Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative cardiovascular products. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
Your responsibilities will include:
- Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
- Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
- Provide quality and compliance input for post market product sustaining activities, such as design changes, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
- Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
- Builds quality into all aspects of work by maintaining compliance to all quality requirements.
- Support internal and external regulatory audits as required.
- Other duties as necessary or required by the organization.
Required qualifications:
- Bachelor’s degree in mechanical, electrical, or biomedical engineering, or equivalent.
- 7+ years of work experience relating to quality assurance in a highly regulated industry.
- Medical device experience
- Competent with use of Microsoft Office Suite
Preferred Qualifications
- Focus on detailed work with emphasis on accuracy and completeness
- Excellent organizational and planning skills; drives for results
- Strong communication (oral and written) and presentation skills
- High energy problem solver capable of driving items to closure
- Ability to collaborate and work on a global team
À propos du poste
L’ingénieur principal en assurance de la qualité de la conception idéal exerce son leadership dans le cadre de projets de développement de nouveaux produits et de projets de soutien pour nos produits cardiovasculaires novateurs. En outre, il développe, établit et assure la mise en œuvre de méthodologies, de systèmes et de pratiques d’ingénierie appliqués à l’assurance de la qualité qui répondent aux exigences de BSC, des clients et des autorités de réglementation.
Responsabilités
- Comprendre les contrôles de conception, la gestion des risques et la facilité d’utilisation des dispositifs médicaux.
- Fournir des informations sur la qualité et la conformité aux équipes responsables des projets en ce qui concerne les décisions à prendre et les produits livrables (c’est-à-dire l’analyse des changements relatifs à la conception, les données d’entrée de la conception, les données de sortie de la conception, les méthodes d’essai, les revues de la conception, la vérification et la validation de la conception, les essais de facilité d’utilisation, la validation des logiciels, la validation des processus et l’étiquetage).
- Fournir des informations sur la qualité et la conformité pour les activités de soutien des produits après leur mise sur le marché, telles que les modifications de la conception, les événements de non-conformité, les besoins d’information prioritaires concernant les actions correctives et préventives, les évaluations des signaux sur le terrain et les actions sur le terrain.
- Appliquer des compétences techniques, y compris des méthodologies éprouvées et systématiques de résolution des problèmes pour identifier, hiérarchiser, communiquer et résoudre les problèmes de qualité.
- Collaborer au sein d’une équipe afin d’identifier et de mettre en œuvre des contrôles efficaces pour soutenir le développement ou la maintenance des produits afin de répondre aux exigences internes et externes.
- Intégrer la qualité dans tous les aspects du travail en maintenant la conformité à toutes les exigences de qualité.
- Soutenir les audits réglementaires internes et externes, le cas échéant.
- Exécuter d’autres tâches requises ou exigées par la société.
Compétences requises
- Baccalauréat en génie mécanique, électrique ou biomédical dans un domaine ou équivalent
- Plus de 7 ans d’expérience professionnelle en matière d’assurance de la qualité dans un secteur hautement réglementé
- Expérience dans le domaine des dispositifs médicaux
- Maîtrise de la suite d’applications Microsoft Office
Compétences souhaitées
- Capacité à se concentrer pour effectuer un travail minutieux en mettant l’accent sur l’exactitude et l’exhaustivité
- Excellentes capacités en matière d’organisation et de planification; volonté d’obtenir des résultats
- Solides compétences en matière de communications (orales et écrites) et de présentation
- Excellente capacité à résoudre les problèmes et à mener les dossiers à terme
- Capacité à collaborer et à travailler au sein d’une équipe internationale
Requisition ID: 617682
Minimum Salary: $79700
Maximum Salary: $158200
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for hourly, non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).
Our organization is across Canada and has commercial representation in 140 countries.
This job involves regular collaboration with colleagues, clients, and stakeholders across Canada, the U.S., and/or internationally, making proficiency in English essential for effective communication and alignment. English is necessary for engaging with a range of documentation and maintaining effective communication if interacting with external clients or vendors.
As detailed in the job description, this job involves communicating, both verbally and in writing, with other Boston Scientific teams located across Canada, the United States and/or with our international clients and partners. International customers and partners represent an important part of our activities. Based on an evaluation, we have determined that the duties of Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualité position require knowledge of English in addition to French (oral and written). We also determined that the English language skills already required of other employees do not permit the performance of English language skills tasks related to Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualité position.
However, in Québec, Boston Scientific limits as much as possible the number of positions for which it requires the knowledge of another language than French. Boston Scientific solely requires proficiency in English where it is necessary for the performance of an employee’s duties.
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